The EU Medical Device Regulation (MDR) requires manufacturers to perform active Post-Market Surveillance (PMS). This means that manufacturers are required to collect and analyse the lifetime data of their devices and upload the data.
However, this requirement can pose intense difficulties for manufacturers whose devices are still largely analogue and depend largely on manual information gathering. CardiLink offers the opportunity to digitise and connect thousands of analogue medical devices in a secure, GDPR- and MDR-compliant manner.
This contributes to increasing uptime and the availability of medical devices, giving victims of SCA better odds of survival, and potentially saving tens of thousands of lives across the globe annually. It also enables manufacturers to offer their distributors better products, while permitting the latter to offer their customers an improved service concept.
CardiLink meets the HealthLevel 7 (HL7) ANSI-accredited standard
for the exchange, integration, and
sharing and retrieval of electronic health information.
Data validation Saves Lives
readiness control of safety equipment: identifies and remedies
renders manual check-ups
safety equipment movement tracking:
Responders with coordinates
Management via software tracking:
reduces waste by extending
Management of servicing & training:
deployment, reducing costs
tracking & status documentation:
verifiable and measurable
compliance of safety procedures and Medical Device Regulations
CardiLink is a customer-individualised and license-based Software as a Service (SaaS) product. If you want to learn more or register a device, please contact us and our team will be happy to evaluate your case.